Specialist Quality Control

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Specialist Quality Control

What you will do

Let’s do this. Let’s change the world. In this vital role you will complete and review analytical testing in our cGMP laboratory. The role will be on-site based out of Amgen Rhode Island and will work under the mentorship of the front-line manager. The QC Bioanalytics team provides analytical expertise in testing the following: in-process, release and stability samples. The laboratory employs a variety of test methodologies that use sophisticated equipment including: HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as: Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing.

Responsibilities:

• Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements

• Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks

• Ensures that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations

• Operate laboratory equipment and instrumentation

• Performs review and approval of assays, documents and records

• Supports Continual Improvement initiatives

• Alerts management of quality, compliance, supply and safety risks

• Participate in laboratory investigations

• Perform general laboratory housekeeping activities

• Completes required assigned training to permit carry through of required tasks

• Performs additional duties as specified by management

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a great teammate with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Quality or Operations experienceOR

• Associate’s degree and 8 years of Quality or Operations experienceOR

• Bachelor’s degree and 4 years of Quality or Operations experienceOR

• Master’s degree and 2 years of Quality or Operations experienceOR

• Doctorate degree

Preferred Qualifications:

• Experience leading teams, projects, or programs

• Experience performing analytical testing per Methods

• Experience with QC analytical systems and/or Quality systems

• Excellent interpersonal, written and verbal communication skills with all levels within the organization

• Ability to work in a team matrix environment and build relationships with partners

• Identify, manage, and champion innovative projects to advance productivity and enable LEAN principles across different functions

• Experience in auditing and defending processes, procedures and decisions during regulatory inspections

• Strong leadership and negotiation skills with a demonstrated ability to influence different styles

• Demonstrated innovative thinking and ability to transform work organizations

• Strong technical writing skills within a highly regulated environment

• Exposure to Operational Excellence initiatives

• Demonstrated ability to navigate through ambiguity and provide a structured problem solving

• Demonstrated ability to coordinate multi-functional project teams and deliver on schedule

• Analytical testing experience in the following technologies: HPLC/UPLC (Glycan, Peptide, SEC, CEX, HIC, and/or Titer), Capillary Electrophoresis (CE SDS, cIEF, and/or cOligo), and/or general chemistry testing including UV, Osmolality, pH, polysorbate, subvisible particles, appearance, color and clarity

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.